Clinical Trial of an Ointment in Patients With Mild and Moderate Atopic Dermatitis

VinUniversity90 enrolled

Overview

Atopic dermatitis (AD) is a chronic skin disorder, which negatively impacts up to 20% children and 3% adults in the world. The main AD treatments aim to regress clinical manifestations, improve and restore skin lesions. Daily moisturizing has also been shown to have the ability to protect the skin, increase skin elasticity and reduce the severity of AD. In the past few decades, Korea has been a well-known country with cosmetic companies and products derived from nature. Carboexpert is also one of them. Since its inception, the company has focused on researching and developing herbal extracts in skin care cosmetic products, typically the product Theraphytoabel Theraphyto Intensive-Cure Ointment. The product uses a high concentration of extract from Syzygium formosum (Wall) masam leaves originating from Vietnam. This is a medicinal herb that has been used in Vietnam for hundreds of years. Folk remedies in Vietnam use hot water leaf extract of this plant to treat urticaria and rashes. Previous studies have shown that leaf extract has also been shown to be very effective against gram-positive bacteria. The study in 2018 also demonstrated that the ethanol extract of S. formosum leaves was effective in reducing food allergy on mouse model. Based on the above evidences, this study will evaluate and compare the effectiveness and safety between Theraphytoabel Theraphyto Intensive-Cure Ointment product and commercial moisturizers which using in Vinmec on moderate and mild AD patients at Vinmec International Hospital Times City, Hanoi.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild and Moderate Atopic Dermatitis Patients

Eligibility

Sex: ALLMin age: 1 YearMax age: 30 Years

Medical Language ↔ Plain English

Inclusion criteria: * Age between 1 and 30 years of age * Definitive diagnosis of AD according to the Hanifin and Rajka criteria SCORAD scores: \< 25: mild AD, 26- 50: moderate AD * Total IgE and eosinophil measurements could be performed to access disease severity Exclusion criteria: * Non-adherence to therapy * Presence of other active skin diseases * Severe AD within 1 month prior to enrollment * Any concomitant disease that in the investigators' judgment, could interdere with treatment * Current systemic treatment or use of immunosuppressive or immunomodulatory agents

Outcomes

Primary Outcomes

Clinical assessment of AD severity

AD global severity will be assessed using the SCORAD index, a validated clinical tool. The intensity of redness, swelling, oozing/ crusting, scratch marks, lichenification and dryness will be measured over the whole body. Subjective symptoms of itch and sleeplessness were measured and skin lesion photographs were taken at every visit.

Time frame: week 0, 4, 8, 12

Secondary Outcomes

Assessment of changes in transepidermal water loss

Transepidermal water loss (TEWL) will be measured to assess changes in skin barrier function at baseline and after treatment using a moisturizer. Measurements will be performed on predefined lesional skin areas using GPSKIN barrier research solution 1 device (GPOWER Inc., Gyeonggi-do, South Korea) throughout the 12-week treatment, under standardized environmental conditions (room temperature 19-25°C and relative humidity 50-58%). Participants will be instructed to avoid applying topical products to the assessment site for at least 12 hours and to acclimatize in the examination room for 15 minutes before measurement. Three consecutive TEWL readings will be obtained at each assessment, and the mean value, expressed in g/m²/h, will be used for analysis.

Time frame: All patients will be measured at week 0 (baseline), 4, 8, 12.

Accessment the changes of Stratum corneum hydration (SCH)

Stratum corneum hydration (SCH) will be assessed to evaluate changes in skin moisture content at baseline and after treatment using a moisturizer. Measurements will be performed on the same predefined lesional skin areas using GPSKIN barrier research solution 1 device (GPOWER Inc., Gyeonggi-do, South Korea) throughout the 12-week treatment, under standardized environmental conditions (room temperature 19-25°C and relative humidity 50-58%). Participants will be instructed to avoid applying topical products to the assessment site for at least 12 hours and to acclimatize in the examination room for 15-20 minutes before measurement. Three consecutive SCH readings will be obtained at each assessment, and the mean value, expressed in arbitrary units (a.u.) will be used for analysis.

Time frame: week 0 (baseline), 4, 8, 12

Evaluate changes in cytokine levels

Cytokine levels of interleukin (IL)-4, IL-13, IL-5 and thymic stromal lymphopoietin (TSLP) in serum will be analyzed using ELISA cytokine kits, Duoset (Bio-Techne, Minneapolis, MN, USA) according to the manufacturer's recommendations.

Time frame: week 0, 12